The primary goal of the Biostatistics Core (BioC) is to facilitate the peer-reviewed research of members of the Comprehensive Cancer Center at Wake Forest University (CCCWFU). We are responsible for collaborating with clinical, cancer control and basic science investigators throughout all phases of cancer-related research projects designed to reduce the incidence of cancer and increase treatment options, improve response and survival, reduce morbidity, manage symptoms, improve health-related quality of life, and move important laboratory discoveries into clinical practice. Major responsibilities are assumed for methodological, statistical, and computer-related issues, including study design, sampling, statistical aspects of clinical trial monitoring, interim reviews, and final analysis. Specifically, we are responsible for 1) ensuring that study designs are adequate, 2) writing the statistical sections for all treatment protocols including plans for interim monitoring of trial results, 3) developing randomization schemes for phase III clinical trials, 4) assisting with the development of sample survey instruments, 5) monitoring ongoing protocol accrual, 6) providing methodological support to CCCWFU investigators, 7) performing interim data analyses, 8) performing ad hoc and final analyses, 9) collaborating in interpreting and publishing results, 10) participating in CCCWFU committees responsible for the scientific and administrative direction of the CCCWFU, 11) conducting a monthly seminar series on topics in research methods for CCCWFU members, and 12) holding statistical assistance planning sessions regularly to assist with grant submissions. In the reported year, July 1, 2004 through June 30,2005, the BioC provided over 3,460 hours of support for cancer related work. The BioC assisted over 70 different investigators from all Programs and Centers of Excellence within the CCCWFU. In addition, 15 investigator-initiated institutional protocols were opened, 18 manuscripts were published and over 20 grants submitted with the assistance of the Biostatistics Core during this time. Over half of the effort provided by the Core (1862.5 hours (54%)) was for performing statistical analyses. An additional 589.5 hours (17%) were spent on grant development, 329 hours (10%) on protocol development, 570.5 hours (16%) on administration and clinical monitoring, and 110 hours (3%) on activities that bridged more than one category. Biostatisticians also provided 1.62 FTEs of effort on external peer-reviewed cancer-related grants as Principal Investigators and Co-investigators during the reported year. For the proposed grant period, we request 1.75 FTEs of statistical support, 0.25 FTEs of administrative support, and 0.20 FTEs of programming support to provide these continued services to Cancer Center members.